INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ACITAB DT

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ACITAB DT

ACITAB-200 DT (Dispersible Tablets)
ACITAB-400 DT (Dispersible Tablets)
ACITAB-800 DT (Dispersible Tablets)

COMPOSITION:
Each ACITAB-200 DT dispersible tablet contains
acyclovir 200 mg.
Each ACITAB-400 DT dispersible tablet contains acyclovir 400 mg.
Each ACITAB-800 DT dispersible tablet contains acyclovir 800 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.8 Antiviral agents.

PHARMACOLOGICAL ACTION:
Acyclovir is a synthetic purine nucleoside analogue used in the treatment of viral infections caused by Herpes simplex virus (HSV) types I and II, as well as Varicella zoster virus (herpes zoster and chickenpox). With the aid of HSV thymidine kinase, acyclovir is taken up into the herpes infected cells and converted via phosphorylation to the active compound, acyclovir triphosphate. Acyclovir triphosphate competitively inhibits herpes specified DNA polymerase, thus preventing further DNA synthesis without affecting normal cellular DNA polymerase.
Pharmacokinetics:
Absorption of acyclovir from the gastrointestinal tract is poor with a bioavailability ranging from 10 to 30%. Protein binding is low (9 to 33%). Peak acyclovir concentrations are achieved within 2 hours of oral administration. In patients with normal renal function, the half-life of acyclovir is approximately 2.5 hours. The half-life is increased in patients with chronic renal failure. Metabolism is hepatic with one inactive metabolite accounting for 14.1% of the excreted acyclovir dose in patients with normal renal function. Elimination is via the kidneys by both glomerular filtration and tubular secretion. Approximately 14% of the total dose is excreted unchanged in the urine with trace amounts excreted via the faeces and lungs.

INDICATIONS:
ACITAB
is indicated for:
Treatment of initial and recurrent Herpes simplex infections of the skin and mucous membranes, including initial and recurrent genital Herpes simplex virus infections, in both immunocompetent and immunocompromised patients.
Suppression of recurrent genital Herpes simplex infections in immunocompetent patients.
Prophylaxis of Herpes simplex infections in immunocompromised patients.
Treatment of Herpes zoster (shingles) infections if the lesions are not older than 72 hours.
Treatment of Varicella zoster (chickenpox) infection within 24 hours after appearance of the typical chickenpox lesions.

CONTRA-INDICATIONS:
Hypersensitivity to acyclovir, valaciclovir or to any components of the formulation.

WARNINGS:
Severe renal impairment - A dose reduction is required in patients with a creatinine clearance of <10 mL/minute.
ACITAB should be used with caution in pregnancy and lactation.

INTERACTIONS:
Although no clinically significant interactions have been reported, any medicine which is excreted via renal tubular secretion may compete with and thus interact with ACITAB. Probenecid has been shown to decrease the renal excretion of acyclovir and to increase the area under the curve (AUC) of acyclovir. No significant increase in toxicity was noted when zidovudine was given together with acyclovir.

PREGNANCY AND LACTATION:
Safety and efficacy in pregnancy and lactation have not been established. Caution should be exercised by balancing the potential benefits of treatment against risk when ACITAB is used in pregnancy and lactation.

DOSAGE AND DIRECTIONS FOR USE:
ACITAB
may be taken with or without meals.

Treatment of initial and recurrent Herpes simplex infections of the skin and mucous membranes:
Adults: 200 mg every four hours, five times per day (omitting the night time dose) for 5 days.
In severe infections, the duration of treatment may be extended.
In severely immunocompromised patients or in patients with impaired gastrointestinal absorption, the dose may be increased to 400 mg five times per day. Alternatively, intravenous administration may be considered.
Treatment should be initiated as early as possible after the start of an infection, or in the case of recurrent episodes, treatment should be started during the prodromal period or when the lesions first appear.
Children (immunocompromised):
Two years and older: Adult dosage.
Under two years: Half the adult dose (limited data).

Suppression of recurrent genital Herpes simplex infections in immunocompetent patients:
Adults: 200 mg four times per day.
Some patients may be adequately treated with 400 mg twice a day, while 200 mg three times per day or even twice a day may also be suitable for some patients. Therapy should be periodically interrupted to reassess the condition.

Prophylaxis of Herpes simplex infections in immunocompromised patients:
Adults: 200 mg four times per day.
In severely immunocompromised patients or in patients with impaired gastrointestinal absorption, the dose may be increased to 400 mg four times per day or changed to intravenous administration.
The duration of prophylactic ACITAB administration is determined by the duration of the period at risk.
Children
: Two years and older: Adult dosage.
Under two years: Half the adult dose (limited data).

Treatment of Varicella zoster infections:
Adults : 800 mg five times per day (omitting the night time dose) for 7 days. Intravenous (IV) administration should be considered for severely immunocompromised patients or in patients with impaired gastrointestinal absorption.
Treatment should be initiated as soon as possible after the rash appears.
Adolescents (12-18 years): 800 mg four times per day for 5 days.
Children (immunocompromised): 20 mg/kg (not to exceed 800 mg) four times a day for 5 days.
Treatment should be started within 24 hours of the occurrence of rash.
In severely immunocompromised children over 2 years of age, the adult dose may be given (limited data).

Severely immunocompromised patients:
Adults: 800 mg four times per day at six hourly intervals.
Bone marrow recipients should receive intravenous (IV) acyclovir 3 times daily for one month prior to receiving oral therapy. Duration of therapy is 6 months and 12 months in patients with advanced HIV disease.

Elderly:
Adequate hydration must be ensured in patients taking high doses of ACITAB. Plasma concentrations of ACITAB are higher in geriatric patients compared to younger patients, in part due to age-related changes in renal function. Dose reductions may be necessary in the elderly with impaired renal function.

Renal function impairment:
Treatment and prophylaxis of Herpes simplex infections:
Mild to moderate impairment - No dose adjustment necessary.
Severe impairment (creatinine clearance less than 10 mL/min) - 200 mg every 12 hours.

Treatment of Varicella and Herpes zoster infections and management of severely immunocompromised patients (usual dose is 800 mg every four hours):
Moderate impairment (creatinine clearance of 10 to 25 mL/min) - 800 mg every 8 hours.
Severe impairment (creatinine clearance of less than 10 mL/min) - 800 mg every 12 hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Haematological disorders:
Less frequent
: Anaemia, leucopenia, thrombocytopenia, neutropenia.

Neuropsychiatric disorders:
Frequent
: Headaches, fatigue, reversible neurological reactions such as dizziness, confusional states, hallucinations, tremors, psychosis, agitation, somnolence, convulsions, coma (especially in patients with renal impairment in whom the dosage was in excess of that recommended).

Gastrointestinal disorders:
Frequent
: Nausea, vomiting, diarrhoea, abdominal pains.

Genitourinary disorders:
Less frequent
: Increases in blood urea and creatinine, acute renal failure.

Hepatobiliary disorders:
Less frequent
: Reversible increases in bilirubin and liver enzymes, hepatitis, jaundice.

Skin and subcutaneous tissue disorders:
Less frequent
: Diffuse hair loss.

Other disorders:
Less frequent
: Hypersensitivity reactions including rash, photosensitivity, urticaria, pruritus, dyspnoea, angioedema, anaphylaxis.

Special precautions:
Care should be taken to maintain adequate hydration in patients receiving high doses of ACITAB.
ACITAB should be administered with caution to patients with renal impairment and doses should be adjusted according to creatinine clearance.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
(see “SIDE-EFFECTS AND SPECIAL PRECAUTIONS”).
Symptoms of overdose:
ACITAB has a wide therapeutic window, therefore excessive doses of ACITAB are generally well tolerated. Repeated overdoses of oral ACITAB have been associated with gastrointestinal effects (such as nausea and vomiting) and neurological effects (such as headache and confusion).
Treatment of overdose:
Treatment is symptomatic and supportive. Haemodialysis, if required, significantly enhances the removal of ACITAB from the blood.

IDENTIFICATION:
ACITAB-200 DT:        white to off-white, circular, flat, bevelled, uncoated tablet with “AC 200” embossed on one face and a central break-line on the other.
ACITAB-400 DT:        white to off-white, circular, flat, bevelled, uncoated tablet with “AC 400” embossed on one face and a central break-line on the other.
ACITAB-800 DT:        white to off-white, capsule-shaped tablet with “AC” embossed on one face and a central break-line on the other.

PRESENTATION:
ACITAB
-200 DT:        Blister packs of 25 tablets.
ACITAB-400 DT:        Blister packs of 56 , 60 or 70 tablets.
ACITAB-800 DT:        Blister packs of 35 tablets.

STORAGE INSTRUCTIONS:
Protect from light.
Store in a dry place , below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
ACITAB
-200 DT:        38/20.2.8/0129
ACITAB-400 DT:        38/20.2.8/0128
ACITAB-800 DT:        38/20.2.8/0130

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD.
Rosen Heights, Pasita Street,
Rosen Park, Bellville 7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 2005

© CIPLA MEDPRO (PTY) LTD

952 UB

New addition to this site: December 2016.
Source: http://www.cipla.co.za/wp-content/uploads/2013/10/sep_acitab-200-dt.pdf

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